AsthmaPhase 4CONNECT1NCT03890666
A 12-Week Treatment Study to Evaluate the Effectiveness of Albuterol Multidose Dry Powder Inhaler With Integrated Electronic Module Digital System (eMDPI DS) in Participants13 Years or Older With Asthma
A Phase 4 study testing Albuterol eMDPI DS and albuterol in people with Asthma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 29 sites in United States.
Trial summary
This is a 12-week treatment, multicenter, open-label, randomized, parallel group comparison feasibility study to evaluate the effectiveness of the Albuterol eMDPI Digital System (DS), including inhaler, App, digital health platform (DHP) (Cloud solution), and dashboard, to optimize outcomes in participants at least 13… Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Albuterol eMDPI DS and albuterol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 333 participants
- Where
- 29 sitesUnited States
- Study dates
- 26 Oct 2020to 4 Oct 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The participant has a documented diagnosis of asthma
- The participant is currently on treatment with an inhaled corticosteroid (ICS) with a long-acting beta2 antagonist (LABA).
- The participant is currently using inhaled albuterol sulfate as rescue medication and is willing to discontinue all other rescue medications and replace them with the study provided Albuterol eMDPI.
- The participant can read and communicate in English and is familiar with and is willing to use his/her own smart device and download and use the App.
- Additional criteria apply, please contact the investigator for more information
Who cannot join
- The participant has any clinically significant uncontrolled medical condition (treated or untreated) other than asthma.
- The participant was hospitalized for severe asthma in the last 30 days.
- The participant has a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or Asthma-COPD Overlap (ACO).
- The participant is a current smoker or has a greater than 10 pack-year history of smoking.
- The participant is currently being treated with systemic corticosteroids (oral, intramuscular, or intravenous) or has been treated within the last 30 days.
- The participant has any treatment with biologics for asthma (for example, omalizumab, anti-IL5, anti-IL5R, anti-IL4R), or has had such treatment within the last 90 days.
- Additional criteria apply, please contact the investigator for more information
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
Teva Investigational Site 14304
Albany, Georgia, 31707
Teva Investigational Site 14233
Ann Arbor, Michigan, 48109
Teva Investigational Site 14197
Aventura, Florida, 33180
Teva Investigational Site 14207
Bellevue, Nebraska, 68123-4303
Teva Investigational Site 14232
Birmingham, Alabama, 35209
Teva Investigational Site 14234
Chapel Hill, North Carolina, 27599
Teva Investigational Site 14300
Charleston, South Carolina, 29407
Teva Investigational Site 14187
Cincinnati, Ohio, 45231
Teva Investigational Site 14236
Colorado Springs, Colorado, 80907
Teva Investigational Site 14198
Denver, Colorado, 80206
Teva Investigational Site 14217
Evanston, Illinois, 60201
Teva Investigational Site 14190
Greenfield, Wisconsin, 53228
Teva Investigational Site 14196
Greenville, South Carolina, 29607
Teva Investigational Site 14302
Los Angeles, California, 90025
Teva Investigational Site 14305
Louisville, Kentucky, 40215
Teva Investigational Site 14306
Miami, Florida, 33186
Teva Investigational Site 14220
New Haven, Connecticut, 06510
Teva Investigational Site 14221
New York, New York, 10461
Teva Investigational Site 14191
Owensboro, Kentucky, 42301
Teva Investigational Site 14210
Philadelphia, Pennsylvania, 19140
Teva Investigational Site 14208
Pittsburgh, Pennsylvania, 15241
Teva Investigational Site 14200
Providence, Rhode Island, 02906
Teva Investigational Site 14188
San Antonio, Texas, 78207
Teva Investigational Site 14192
San Antonio, Texas, 78229
Teva Investigational Site 14189
San Antonio, Texas, 78251
Teva Investigational Site 14215
Sarasota, Florida, 34239
Teva Investigational Site 14195
Savannah, Georgia, 31406
Teva Investigational Site 14218
Springfield, Illinois, 62704
Teva Investigational Site 14301
Stockton, California, 95207-6204
About this study
Official title: CONNected Electronic Inhalers Asthma Control Trial 1 ("CONNECT 1"), a 12-Week Treatment, Multicenter, Open-Label, Randomized, Parallel Group Comparison, Feasibility Study to Evaluate the Effectiveness of the Albuterol eMDPI Digital System, to Optimize Outcomes in Patients at Least 13 Years of Age or Older With Asthma
This is a 12-week treatment, multicenter, open-label, randomized, parallel group comparison feasibility study to evaluate the effectiveness of the Albuterol eMDPI Digital System (DS), including inhaler, App, digital health platform (DHP) (Cloud solution), and dashboard, to optimize outcomes in participants at least 13 years of age or older with asthma.
The study will consist of a screening visit, a 12-week open-label treatment period, and a follow-up telephone call (2 weeks following treatment completion).
Participants with suboptimal asthma control will be enrolled in the study and randomized in a 1:1 ratio to 1 of 2 parallel groups stratified by investigational center: DS group participants utilizing the Albuterol eMDPI DS, including inhaler, App, DHP (Cloud solution), and dashboard, and CC group participants who will be treated with their standard of care albuterol-administering rescue inhalers and will not use the DS during the treatment period.
- Conditions
- Asthma
- Being tested
- Albuterol eMDPI DS, albuterol
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albuterol eMDPI DSDrug
Albuterol sulfate electronic multidose dry powder inhaler (Albuterol eMDPI) DS with 4 component devices:
- Device 1: Albuterol eMDPI
- Device 2: Albuterol eMDPI Patient-facing smart device application (App)
- Device 3: DHP Cloud solution)
- Device 4: Provider-facing dashboard (dashboard)
albuterolDrug
Standard of care albuterol-administering rescue inhaler
| Study group | Role | What they receive |
|---|---|---|
| Digital System (DS) | Experimental | Participants will be trained on the use of the albuterol eMDPI DS (including instructions on how to use both the eMDPI and the App) and, upon demonstrating competency, will receive 2 albuterol eMDPI devices for use as reliever bronchodilators to replace their reliever treatment during the study. The eMDPI Digital System consists of 4 devices: Device 1: albuterol eMDPI (the test investigational medicinal product [IMP]); Device 2: Patient-facing App; Device 3: Digital health platform (DHP) (Cloud solution); and Device 4: Provider-facing Dashboard. Participants will receive 90 micrograms (mcg) albuterol, 1 to 2 oral inhalations every 4 to 6 hours, as needed for 12 weeks. Receives: Drug: Albuterol eMDPI DS |
| Concurrent Control (CC) | Active comparator | Participants will be treated with their standard of care albuterol-administering reliever inhalers and will use the digital system during the treatment period. Participants will be reimbursed or given a voucher to use to purchase their existing reliever medications. Receives: Drug: albuterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving Meaningful Asthma Improvement at the End of 12-Week Treatment Period
Meaningful asthma improvement was defined as an Asthma Control Test (ACT) score of at least 20 at the end of the 12-week treatment period or an increase of at least 3 units on the ACT score from baseline at the end of the 12-week treatment period. The ACT was a simple, participant-completed tool used to assess overall asthma control. The 5 items included in the ACT assess daytime and night-time asthma symptoms, use of reliever medication, and impact of asthma on daily functioning. Each item in the ACT was scored on a 5-point scale, with a summation of all items providing scores ranging from 5 to 25. The scores span the continuum of poor control of asthma (score of 5) to complete control of asthma (score of 25), with a cutoff score of 19 and below indicating participants with poorly controlled asthma.
Measured: Baseline to Week 12
Secondary outcomes (16)
Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence
Number of participants who had discussions with iHCP regarding inhaler technique or adherence are reported.
Measured: Baseline up to Week 12
Number of Decreased Doses of Inhaled Medication
Number of participants who received decreased dose of inhaled medication during the 12-week treatment period are reported.
Measured: Baseline up to Week 12
Number of Increased Doses of Inhaled Medication
Number of participants who received increased dose of inhaled medication during the 12-week treatment period are reported.
Measured: Baseline up to Week 12
Number of Changes to Different Inhaled Medication
Number of participants who received different inhaled medication during the 12-week treatment period are reported.
Measured: Baseline up to Week 12
Number of Additional Inhaled Medication
Number of participants who received additional inhaled medication during the 12-week treatment period are reported.
Measured: Baseline up to Week 12
Number of Addition of a Systemic Corticosteroid Medication for Asthma Therapy
Number of participants who received additional systemic corticosteroid medication for asthma therapy during the 12-week treatment period are reported.
Measured: Baseline up to Week 12
Frequency of Intervention to Manage Comorbid Conditions Associated With Poor Asthma Control
Number of participants with different frequency of intervention to manage comorbid conditions such as Gastroesophageal Reflux Disease (GERD) and Sinusitis are reported.
Measured: Baseline up to Week 12
Change From Baseline in Mean Weekly Short-acting Beta2 Agonist (SABA) Usage at Week 12 for the DS Group
Measured: Baseline, Week 12
Change From Baseline in the Number of SABA-free Days at Week 12 for the DS Group
Measured: Baseline, Week 12
System Usability Scale (SUS) Overall Score
The SUS was used to explore device acceptability and usability for participants in the DS group. It covered a variety of aspects of system usability, such as the need for support, training, and complexity, and thus giving a global view of subjective assessments of usability. It was a 10-question tool (with five response options; from 1=strongly disagree to 5=strongly agree) that provided a composite measure, ranging from 0 to 100, of the overall usability of the system being studied. Higher scores represent better usability level for the tool.
Measured: Week 12
Change From Baseline in Beliefs About Medicines Questionnaire (BMQ) Concern Subscale Score at Week 12
The BMQ was used to assess cognitive representations of medicine. The Beliefs About Medicines Questionnaire-Specific 11 (BMQ-S11) was an 11-item questionnaire that assessed the representation of medication prescribed for personal use and the BMQ-General assesses beliefs about medicines in general. BMQ concern is a 6-item scale assessing participant's concerns about potential adverse consequences (range: 1=strongly disagree to 5=strongly agree). Participants indicated their degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by the total number of items and multiplied by 5 to give a total score ranging from 5 to 25 (higher scores=stronger beliefs).
Measured: Baseline, Week 12
Change From Baseline in BMQ Necessity Subscale Score at Week 12
The BMQ was used to assess cognitive representations of medicine. The Beliefs About Medicines Questionnaire-Specific 11 (BMQ-S11) was an 11-item questionnaire that assessed the representation of medication prescribed for personal use and the BMQ-General assesses beliefs about medicines in general. BMQ necessity is a 5-item scale assessing participant's beliefs about necessity of medications for controlling disease. Participants indicated degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by the total number of items and multiplied by 5 to give a total score ranging from 5 to 25 (higher scores=stronger beliefs).
Measured: Baseline, Week 12
Change From Baseline in Brief Illness Perception Questionnaire (BIPQ) Illness Comprehensibility Subscale Score at Week 12
The BIPQ was a 9-item questionnaire designed to rapidly assess cognitive and emotional representations of illness. Only one item assesses illness comprehensibility or coherence of illness (Item 7: How well do you feel you understand your illness?). This item was rated using a 0 (do not understand at all) to 10 (understand very clearly) response scale. A higher score indicates a stronger illness comprehensibility.
Measured: Baseline, Week 12
Change From Baseline in BIPQ Cognitive Subscale Score at Week 12
BIPQ was a 9-item questionnaire designed to rapidly assess cognitive and emotional representations of illness. It comprised 5 items on cognitive representation of illness perception: consequences (Item 1: How much does your illness affect your life? Response range 0 [no affect] - 10 [severe affect]), timeline (Item 2: How long do you think your illness will continue? Response range 0 [a very short time] - 10 [forever]), personal control (Item 3: How much control do you feel you have over your illness? Response range 0 [no control] - 10 [extreme amount of control]), treatment control (Item 4: How much do you think your treatment can help your illness? Response range 0 [not at all] - 10 [extremely helpful]), and identity (Item 5: How much do you experience symptoms from your illness? Response range 0 [no symptoms] - 10 [severe symptoms]). Total BIPQ Cognitive Subscale Score was the sum of all item score and ranged from 0 to 50. A higher score indicates stronger illness perception.
Measured: Baseline, Week 12
Change From Baseline in BIPQ Emotional Representations Subscale Score at Week 12
BIPQ was a 9-item questionnaire designed to rapidly assess cognitive and emotional representations of illness. It comprised 2 items on emotional representation: concern (Item 6: How concerned are you about your illness? Response range 0 [not at all concerned] - 10 [extremely concerned]) and emotions (Item 8: How much does your illness affect you emotionally; for example, does it make you angry, scared, upset or depressed? Response range 0 [not at all affected emotionally] - 10 [extremely affected emotionally]). Total BIPQ Emotional Subscale Score was the sum of above 2 items score and ranged from 0 to 20. A higher score indicates extreme emotional representation.
Measured: Baseline, Week 12
Number of Participants With Adverse Events (AEs)
An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'. Number of participants with any AEs, treatment-related AEs, and device-related AEs has been reported.
Measured: Baseline up to Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start26 Oct 2020
- Primary completion4 Oct 2021
- Study completion4 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 333 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Teva Medical Expert, MD, Study director, Teva Branded Pharmaceutical Products R&D, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03890666
- Sponsor's protocol ID
- ABS-AS-40138
- Acronym
- CONNECT1
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2019
- Last updated
- 19 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CONNected Electronic Inhalers Asthma Control Trial 1 ("CONNECT 1"), a 12-Week Treatment, Multicenter, Open-Label, Randomized, Parallel Group Comparison, Feasibility Study to Evaluate the Effectiveness of the Albuterol eMDPI Digital System, to Optimize Outcomes in Patients at Least 13 Years of Age or Older With Asthma
- ClinicalTrials.gov ID
- NCT03890666
- Acronym / sponsor ID
- CONNECT1 / ABS-AS-40138
- Conditions
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 333 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Oct 2020 (actual)
- Primary completion
- 4 Oct 2021 (actual)
- Study completion
- 4 Oct 2021 (actual)
- First posted
- 26 Mar 2019 (actual)
- Results
- Posted 27 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 12-week treatment, multicenter, open-label, randomized, parallel group comparison feasibility study to evaluate the effectiveness of the Albuterol eMDPI Digital System (DS), including inhaler, App, digital health platform (DHP) (Cloud solution), and dashboard, to optimize outcomes in participants at least 13 years of age or older with asthma.
The study will consist of a screening visit, a 12-week open-label treatment period, and a follow-up telephone call (2 weeks following treatment completion).
Participants with suboptimal asthma control will be enrolled in the study and randomized in a 1:1 ratio to 1 of 2 parallel groups stratified by investigational center: DS group participants utilizing the Albuterol eMDPI DS, including inhaler, App, DHP (Cloud solution), and dashboard, and CC group participants who will be treated with their standard of care albuterol-administering rescue inhalers and will not use the DS during the treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital System (DS) | Experimental | Drug: Albuterol eMDPI DSParticipants will be trained on the use of the albuterol eMDPI DS (including instructions on how to use both the eMDPI and the App) and, upon demonstrating competency, will receive 2 albuterol eMDPI devices for use as reliever bronchodilators to replace their reliever treatment during the study. The eMDPI Digital System consists of 4 devices: Device 1: albuterol eMDPI (the test investigational medicinal product [IMP]); Device 2: Patient-facing App; Device 3: Digital health platform (DHP) (Cloud solution); and Device 4: Provider-facing Dashboard. Participants will receive 90 micrograms (mcg) albuterol, 1 to 2 oral inhalations every 4 to 6 hours, as needed for 12 weeks. |
| Concurrent Control (CC) | Active comparator | Drug: albuterolParticipants will be treated with their standard of care albuterol-administering reliever inhalers and will use the digital system during the treatment period. Participants will be reimbursed or given a voucher to use to purchase their existing reliever medications. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- The participant has a documented diagnosis of asthma
- The participant is currently on treatment with an inhaled corticosteroid (ICS) with a long-acting beta2 antagonist (LABA).
- The participant is currently using inhaled albuterol sulfate as rescue medication and is willing to discontinue all other rescue medications and replace them with the study provided Albuterol eMDPI.
- The participant can read and communicate in English and is familiar with and is willing to use his/her own smart device and download and use the App.
Key exclusion criteria (7 listed)
- The participant has any clinically significant uncontrolled medical condition (treated or untreated) other than asthma.
- The participant was hospitalized for severe asthma in the last 30 days.
- The participant has a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or Asthma-COPD Overlap (ACO).
- The participant is a current smoker or has a greater than 10 pack-year history of smoking.
- The participant is currently being treated with systemic corticosteroids (oral, intramuscular, or intravenous) or has been treated within the last 30 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Albuterol eMDPI DSAlbuterol sulfate electronic multidose dry powder inhaler (Albuterol eMDPI) DS with 4 component devices: * Device 1: Albuterol eMDPI * Device 2: Albuterol eMDPI Patient-facing smart device application (App) * Device 3: DHP Cloud solution) * Device 4: Provider-facing dashboard (dashboard) | Drug | Digital System (DS) |
| albuterolStandard of care albuterol-administering rescue inhaler | Drug | Concurrent Control (CC) |
Primary outcome
Percentage of Participants Achieving Meaningful Asthma Improvement at the End of 12-Week Treatment Period
Time frame: Baseline to Week 12
Meaningful asthma improvement was defined as an Asthma Control Test (ACT) score of at least 20 at the end of the 12-week treatment period or an increase of at least 3 units on the ACT score from baseline at the end of the 12-week treatment period. The ACT was a simple, participant-completed tool used to assess overall asthma control. The 5 items included in the ACT assess daytime and night-time asthma symptoms, use of reliever medication, and impact of asthma on daily functioning. Each item in the ACT was scored on a 5-point scale, with a summation of all items providing scores ranging from 5 to 25. The scores span the continuum of poor control of asthma (score of 5) to complete control of asthma (score of 25), with a cutoff score of 19 and below indicating participants with poorly controlled asthma.
16 secondary outcomes
Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence
Time frame: Baseline up to Week 12
Number of Decreased Doses of Inhaled Medication
Time frame: Baseline up to Week 12
Number of Increased Doses of Inhaled Medication
Time frame: Baseline up to Week 12
Number of Changes to Different Inhaled Medication
Time frame: Baseline up to Week 12
Number of Additional Inhaled Medication
Time frame: Baseline up to Week 12
Number of Addition of a Systemic Corticosteroid Medication for Asthma Therapy
Time frame: Baseline up to Week 12
Frequency of Intervention to Manage Comorbid Conditions Associated With Poor Asthma Control
Time frame: Baseline up to Week 12
Change From Baseline in Mean Weekly Short-acting Beta2 Agonist (SABA) Usage at Week 12 for the DS Group
Time frame: Baseline, Week 12
Change From Baseline in the Number of SABA-free Days at Week 12 for the DS Group
Time frame: Baseline, Week 12
System Usability Scale (SUS) Overall Score
Time frame: Week 12
Change From Baseline in Beliefs About Medicines Questionnaire (BMQ) Concern Subscale Score at Week 12
Time frame: Baseline, Week 12
Change From Baseline in BMQ Necessity Subscale Score at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Brief Illness Perception Questionnaire (BIPQ) Illness Comprehensibility Subscale Score at Week 12
Time frame: Baseline, Week 12
Change From Baseline in BIPQ Cognitive Subscale Score at Week 12
Time frame: Baseline, Week 12
Change From Baseline in BIPQ Emotional Representations Subscale Score at Week 12
Time frame: Baseline, Week 12
Number of Participants With Adverse Events (AEs)
Time frame: Baseline up to Week 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teva Medical Expert, MD study director
Teva Branded Pharmaceutical Products R&D, Inc.
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Albuterol eMDPI DS and albuterol in people with Asthma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 29 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving Meaningful Asthma Improvement at the End of 12-Week Treatment Period (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.